This invention relates to a device and method for implanting living cells within a host.
It is desirable to treat various cell and molecular deficiency diseases by transferring cells into a patient having the disease. In theory, the implanted cells will generate biological products in the host that the host, because of disease or injury, cannot produce, has a deficiency, or requires for treatment, and/or modulation of a particular condition.
However, in practice, transferred cells are often rejected by the patient""s immune system or become a threat to the host. Thus, the transplanted or implanted cells are not kept alive for a time sufficient to provide the intended therapeutic benefit.
Therefore, there is a need for an implant device and method which will increase the rate of successful implantation and to increase the long term viability of implanted cells.
The invention provides a device and method for implanting a cell culture in a host. The device includes a biocompatible deformable body, a biocompatible microporous membrane and a sealable port. The deformable body comprises a wall, wherein the wall defines at least one aperture. Preferably, the deformable body is in the shape of a sphere, cylinder, ovoid or ellipsoid. Preferably, the wall of the deformable body defines a plurality of apertures. In one embodiment, the wall comprises a mesh.
The biocompatible microporous membrane is supported by the deformable body such that the deformable body and microporous membrane define a cavity. The cavity is capable of containing a cell culture. Preferably the microporous membrane has openings that are sized to allow passage, for example, by diffusion, of a therapeutic substance produced by the cell culture into the host and/or to allow nutrients or biomolecules produced by the host to pass into the cavity. The microporous membrane preferably comprises a microporous polymeric material such as linear polyesters of carbonic acid, poly(vinylchloride), polyamides, styrene-acrylic acid copolymers, polysulfones, halogenated poly(vinylidene), polychloroethers, poly(urethanes) and poly(imides). In one embodiment, the microporous membrane lines an internal surface of the deformable body. In another embodiment, the microporous membrane lines an external surface of the deformable body.
The sealable port is adapted and configured for adding the cell culture to the cavity. In one embodiment, the sealable port is a sealing hub formed of a material that is capable of resealing after being punctured with a needle. Preferably, the sealing hub is formed of silicone and is maintained under pressure, for example, compressed into an aperture of the deformable body.
In one embodiment, the device can include a coating material covering a surface of the microporous membrane proximate to the cavity. Preferably, the coating material is a biologically active material that facilitates attachment of cells to the microporous membrane, for example, by ionic or covalent bonding. Examples of suitable biologically active materials include extracellular matrix molecules (ECMs), such as laminins, tenascins, collagens, netrins, semaphorin, thrombospondin, fibronectin, vitronectin, proteoglycan and biologically active fragments thereof, wherein the biologically active fragment includes a specific binding sequence of the ECM. Alternately, the biologically active material includes cell-cell adhesion molecules (CAMs), such as caherin superfamily or immunoglobulin (Ig) superfamily molecules (NCAM or fibronectins).
The invention also provides a method for implanting a cell culture in a host, administering a therapeutic substance to a host and a method of treating a disease using the device.